InsomniaNCT04949360
SleepUp Digital CBTi-based Platform for Insomnia
A study testing Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies, Regular Cognitive Behavioural Therapy for Insomnia and Sleep hygiene - minimal intervention in people with Insomnia and Sleep Disorder, run by SleepUp Tecnologia em Saúde Ltda at 1 site in Brazil.
Trial summary
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Insomnia, Sleep Disorder, Sleep Hygiene
- What is being tested?
- Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies, Regular Cognitive Behavioural Therapy for Insomnia and Sleep hygiene - minimal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- 19 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Literate Brazilian portuguese speakers.
- Insomnia symptoms (as measured by ISI).
- An Android-based smartphone or tablet with access to the Internet.
Who cannot join
- Previous experience with CBTi.
- Use of sleeping pills or any other treatment for insomnia for two or more days a week in the last three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
SleepUp Tecnologia em Saúde LTDA
São Caetano do Sul, São Paulo, 09530-250
Renata Bonaldi, PhD, +55 11 95555-6467, renata.bonaldi@sleepup.com.br
About this study
Official title: Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia and will be conducted in 2 phases.
Phase 1
Read more
The sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups:
- Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists).
- Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral
- Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
Phase 2
This phase will comprise 120 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in three groups:
- Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral
- Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
Read the detailed description
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. In its standard presentation, it is composed by 6 to 12 weekly appointments with a board-certified sleep psychologist. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia.
The participants will be recruited based on advertising on social media and invited to participate. Those participants who are eligible in accordance to the inclusion and exclusion criteria will be contact by a member of the research team who will provide a consent form and will explain the terms and conditions of this research project. The sample will be composed of 160 individuals in Phase 1 and by 120 individuals in Phase 2, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild, according to the Insomnia Severity Index (ISI). All groups shall have similar proportions of gender and of insomnia symptoms severity.
Phase 1
Those who accepted to participate will be randomized and distributed in four groups:
- Standard CBTi (CBTi-S): This is a positive control group, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structure appointments with psychologists. Only psychologists board-certified in sleep medicine will perform the CBTi sessions, and none of them are part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi.
- Minimal intervention - Sleep hygiene (MI-SH): This group corresponds to a negative control group, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral nature of insomnia.
- Online CBTI (CBTI-O): This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
Phase 2
Those who accepted to participate will be randomized and distributed in three groups:
- Minimal intervention - Sleep hygiene (MI-SH): This group corresponds to a negative control group, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral nature of insomnia.
- Online CBTI (CBTI-O): This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
All participants in all groups will be assessed periodically throughout the eight weeks of intervention. Equivalent intervals will be applied to the SH-MI group. The following clinical questionnaires and scales will be used:
- Sleep log: It includes self-reported items regarding wake and bedtime, sleep latency and other sleeping habits. It allows the calculation of total sleep time, sleep efficiency and wake time after sleep onset. Fille daily.
- Morningness and Eveningness Questionnaire: It evaluates chronotype based on 19 items, allowing categorizing the participants according to the following categories: morning type (definitive or moderate), intermediate, or evening type (definitive or moderate). Applied once, in the first week of follow up.
- Insomnia Severity Index: It evaluates the presence and severity of insomnia, categorizing the participants according to the following categories: no, mild, moderate or severe insomnia. Applied once every two weeks.
- Epworth Sleepiness Scale: It evaluates excessive daytime sleepiness by inquiring about the chance of sleeping in eight daily situations. Scores higher than 10 indicates excessive daytime sleepiness. Applied once every two weeks.
- Pittsburgh Sleep Quality Index: It evaluates overall sleep quality based on 19 self-reported items. Scores higher than 5 indicates poor sleep quality. Applied once every two weeks.
- Sleep Hygiene Index: It habits related to sleep hygiene, based on 13 self-reported items.
- Conditions
- Insomnia, Sleep Disorder, Sleep Hygiene
- Being tested
- Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies, Regular Cognitive Behavioural Therapy for Insomnia, Sleep hygiene - minimal intervention
- Keywords
- Insomnia, Sleep, Cognitive-behavioral therapy, CBTi
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive-Behavioral Therapy for Insomnia and complementary therapiesBehavioural
The CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks.
Regular Cognitive Behavioural Therapy for InsomniaBehavioural
This is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls.
Sleep hygiene - minimal interventionBehavioural
It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by SleepUp app.
| Study group | Role | What they receive |
|---|---|---|
| Standard CBTi (CBTi-S): | Active comparator | This is a positive control group/active comparator, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structured appointments with a board-certified sleep psychologist. The professionals performing the CBTi sessions will not be part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi. Receives: Behavioral: Regular Cognitive Behavioural Therapy for Insomnia |
| Minimal intervention - Sleep hygiene (MI-SH): | Placebo comparator | This group corresponds to a negative control group/placebo comparator, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no-treatment or waiting list controls, due to the behavioral nature of insomnia. Receives: Behavioral: Sleep hygiene - minimal intervention |
| Online CBTI (CBTI-O) | Experimental | This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version, and all features other than the CBTi track will be removed. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform. Receives: Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies |
| Online CBTi + additional features (CBTi-O+) | Experimental | This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth. Receives: Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the treatment
It will be measured as the percentage of participants who completed the treatment, out of those who effectively initiated it. Dropouts will be considered whenever a participants fail to comply with the tasks relative to each group for two consecutive weeks, or postpone the completion of these tasks for three times. These tasks refer to the responses to periodic questionnaires and to the completion of the CBTi or CBTi-O sessions (when applicable).The aim of this comparison is to evaluate whether the adherence rate in the CBTi-O and CBTi-O+ groups are similar to the standard treatment (CBTi-S) or higher than the minimal treatment (MI-SH).
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Response to treatment
Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Remission of symptoms
Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Secondary outcomes (6)
Self-reported sleep efficiency
Sleep efficiency will be measured by sleep logs
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Sleep hygiene
Sleep hygiene habits will be measured by the Sleep Hygiene Index
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Excessive daytime sleepiness
Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep latency
Sleep latency will be measured by sleep logs
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep duration
Sleep duration will be measured by sleep logs
Measured: From enrollment (baseline) to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start19 May 2025
- Primary completion18 Nov 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1=Participants will be randomized and distributed in four parallel and independent groups. Phase 2=Participants will be randomized and distributed in three parallel and independent groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SleepUp Tecnologia em Saúde Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel N. Pires, PhD, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949360
- Sponsor's protocol ID
- SleepUp_#01
- Other IDs
- 34113520.1.0000.5494
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT04949360
- Acronym / sponsor ID
- SleepUp_#01
- Conditions
- Insomnia, Sleep Disorder, Sleep Hygiene
- Keywords
- Insomnia, Sleep, Cognitive-behavioral therapy, CBTi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- SleepUp Tecnologia em Saúde LtdaIndustry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia and will be conducted in 2 phases.
Phase 1
The sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups:
- Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists).
- Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral
- Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
Phase 2
This phase will comprise 120 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in three groups:
- Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral
- Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
Detailed description
Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. In its standard presentation, it is composed by 6 to 12 weekly appointments with a board-certified sleep psychologist. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia.
The participants will be recruited based on advertising on social media and invited to participate. Those participants who are eligible in accordance to the inclusion and exclusion criteria will be contact by a member of the research team who will provide a consent form and will explain the terms and conditions of this research project. The sample will be composed of 160 individuals in Phase 1 and by 120 individuals in Phase 2, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild, according to the Insomnia Severity Index (ISI). All groups shall have similar proportions of gender and of insomnia symptoms severity.
Phase 1
Those who accepted to participate will be randomized and distributed in four groups:
- Standard CBTi (CBTi-S): This is a positive control group, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structure appointments with psychologists. Only psychologists board-certified in sleep medicine will perform the CBTi sessions, and none of them are part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi.
- Minimal intervention - Sleep hygiene (MI-SH): This group corresponds to a negative control group, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral nature of insomnia.
- Online CBTI (CBTI-O): This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
Phase 2
Those who accepted to participate will be randomized and distributed in three groups:
- Minimal intervention - Sleep hygiene (MI-SH): This group corresponds to a negative control group, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral nature of insomnia.
- Online CBTI (CBTI-O): This group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
- Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.
All participants in all groups will be assessed periodically throughout the eight weeks of intervention. Equivalent intervals will be applied to the SH-MI group. The following clinical questionnaires and scales will be used:
- Sleep log: It includes self-reported items regarding wake and bedtime, sleep latency and other sleeping habits. It allows the calculation of total sleep time, sleep efficiency and wake time after sleep onset. Fille daily.
- Morningness and Eveningness Questionnaire: It evaluates chronotype based on 19 items, allowing categorizing the participants according to the following categories: morning type (definitive or moderate), intermediate, or evening type (definitive or moderate). Applied once, in the first week of follow up.
- Insomnia Severity Index: It evaluates the presence and severity of insomnia, categorizing the participants according to the following categories: no, mild, moderate or severe insomnia. Applied once every two weeks.
- Epworth Sleepiness Scale: It evaluates excessive daytime sleepiness by inquiring about the chance of sleeping in eight daily situations. Scores higher than 10 indicates excessive daytime sleepiness. Applied once every two weeks.
- Pittsburgh Sleep Quality Index: It evaluates overall sleep quality based on 19 self-reported items. Scores higher than 5 indicates poor sleep quality. Applied once every two weeks.
- Sleep Hygiene Index: It habits related to sleep hygiene, based on 13 self-reported items.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Phase 1=Participants will be randomized and distributed in four parallel and independent groups. Phase 2=Participants will be randomized and distributed in three parallel and independent groups.
| Arm | Type | Receives |
|---|---|---|
| Standard CBTi (CBTi-S): | Active comparator | Behavioral: Regular Cognitive Behavioural Therapy for InsomniaThis is a positive control group/active comparator, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structured appointments with a board-certified sleep psychologist. The professionals performing the CBTi sessions will not be part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi. |
| Minimal intervention - Sleep hygiene (MI-SH): | Placebo comparator | Behavioral: Sleep hygiene - minimal interventionThis group corresponds to a negative control group/placebo comparator, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no-treatment or waiting list controls, due to the behavioral nature of insomnia. |
| Online CBTI (CBTI-O) | Experimental | Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapiesThis group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version, and all features other than the CBTi track will be removed. This way, the participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform. |
| Online CBTi + additional features (CBTi-O+) | Experimental | Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapiesThis group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Literate Brazilian portuguese speakers.
- Insomnia symptoms (as measured by ISI).
- An Android-based smartphone or tablet with access to the Internet.
Key exclusion criteria (2 listed)
- Previous experience with CBTi.
- Use of sleeping pills or any other treatment for insomnia for two or more days a week in the last three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Cognitive-Behavioral Therapy for Insomnia and complementary therapiesThe CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks. | Behavioural | Online CBTI (CBTI-O), Online CBTi + additional features (CBTi-O+) |
| Regular Cognitive Behavioural Therapy for InsomniaThis is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls. | Behavioural | Standard CBTi (CBTi-S): |
| Sleep hygiene - minimal interventionIt is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by SleepUp app. | Behavioural | Minimal intervention - Sleep hygiene (MI-SH): |
Primary outcome
Adherence to the treatment
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
It will be measured as the percentage of participants who completed the treatment, out of those who effectively initiated it. Dropouts will be considered whenever a participants fail to comply with the tasks relative to each group for two consecutive weeks, or postpone the completion of these tasks for three times. These tasks refer to the responses to periodic questionnaires and to the completion of the CBTi or CBTi-O sessions (when applicable).The aim of this comparison is to evaluate whether the adherence rate in the CBTi-O and CBTi-O+ groups are similar to the standard treatment (CBTi-S) or higher than the minimal treatment (MI-SH).
Response to treatment
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.
Remission of symptoms
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.
6 secondary outcomes
Self-reported sleep efficiency
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Sleep hygiene
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Excessive daytime sleepiness
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Sleep quality
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep latency
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep duration
Time frame: From enrollment (baseline) to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.
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Poor Sleep Quality, Gut Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel N. Pires, PhD principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies, Regular Cognitive Behavioural Therapy for Insomnia and Sleep hygiene - minimal intervention in people with Insomnia and Sleep Disorder, run by SleepUp Tecnologia em Saúde Ltda at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pesquisa SleepUp (+55 11 93319-1375, pesquisa@sleepup.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the treatment (time frame: From enrollment (baseline) to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.